BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2012466 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02960
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A CHECK LINES AND BAGS (CLB) ALARM. SAMPLE WAS NOT RETURNED, THEREFORE COMPLAINT CANNOT BE CONFIRMED IN THE LAB. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. PER THE COMPLAINT INFORMATION, AFTER THE ALARM, THE PATIENT REPLACED THE CASSETTE, HOWEVER REUSED THE SOLUTION BAGS. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE REPORTED USER ERRORS IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) ALARM SITUATION CHECK LINES AND BAGS ALARM, THIS SITUATION OCCURRED DURING PRIME. THE HOME PATIENT (HP) STATED SHE TRIED CHANGING THE CASSETTE THAT NIGHT AND WAS STILL GETTING THE ALARM. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASKED THE HP IF SHE CHANGED THE BAGS WHEN SHE CHANGED THE CASSETTE AND THE HP STATED NO. THE TSR EXPLAINED THE SETUP WAS COMPROMISED AND THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP WANTED TO KNOW WHY SHE WAS GETTING THE ALARM AND THE TSR EXPLAINED THE POSSIBLE CAUSES. THE TSR INSTRUCTED THE HP TO TURN OFF THE MACHINE, DISCARD THE SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE. PER THE HP, SHE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SETUP AT THE TIME OF THE ALARM. THE HP DISCARDED THE SUPPLIES AND THE LOT NUMBER WAS GIVEN. THE HP RESUMED THERAPY USING NEW SUPPLIES WITHOUT ANY PROBLEMS. THE WRITER ASKED THE HP IF SHE HAD CONTACTED HER PD RN REGARDING CHANGING ONLY THE CASSETTE AFTER THE ALARM AND THE HP STATED SHE HAD NOT. THE WRITER ADVISED THE HP THAT SHE SHOULD LET HER KNOW AS THE SET WAS COMPROMISED. THE HP IS AWARE OF THE PROPER PROCEDURES AND WILL LET HER PD RN KNOW. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11A19096

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR HOMECHOICE